CN110101505B

CN110101505B - Surgical aseptic dressing bag

Info

Publication number: CN110101505B
Application number: CN201910345307.8A
Authority: CN
Inventors: 陈仲璜
Original assignee: Zhuhai Gaoxian Operation Product Technology Co ltd
Current assignee: Zhuhai Gaoxian Operation Product Technology Co ltd
Priority date: 2019-04-26
Filing date: 2019-04-26
Publication date: 2021-10-22
Anticipated expiration: 2039-04-26
Also published as: CN110101505A

Abstract

The invention discloses an operation sterile dressing bag, which comprises an outer bag and a dressing, wherein the outer bag is sterile sealed package; at least two dressings are sealed in the outer package, each dressing is formed into a multi-layer structure which is folded into a preset size before being packaged in the outer package, each dressing is provided with an X-ray tracing piece, and the colors of the X-ray tracing pieces are different. The sterile dressing bag for the operation provided by the invention can enable the dressing to be detected under X-rays more easily in minor operations, so that the dressing is taken out from a patient body more easily, and the X-ray tracing pieces with different colors are used as visual aids, so that the counting standard of the dressing is more accurate.

Description

Surgical aseptic dressing bag

Technical Field

The invention relates to the technical field of medical articles, in particular to an operation sterile dressing bag.

Background

Surgical dressings are used to absorb blood and body secretions during surgery, and for large procedures with large incisions, larger sized surgical dressings such as abdominal pads and surgical drapes are used, which typically have an X-ray tracker for X-ray machine detection and a retrieval handle to pull the dressing from the surgical site. Whereas for small procedures with small incisions, smaller-sized surgical dressings are used, commonly referred to as X-ray tracing gauze patches, unlike large-sized surgical dressings, the X-ray tracing gauze patches do not need to be provided with a retrieval handle, since it may interfere with the procedure at the site of the small incision, and is more costly. When current carry out small-size operation, take the gauze piece of X-ray pursuit line to detect when surveying very difficultly to the counting process is complicated, causes easily to leave over in the patient is internal.

Disclosure of Invention

The present invention is directed to solving, at least to some extent, one of the technical problems in the related art. To this end, a first object of the invention is to propose a surgical sterile dressing pack comprising:

the outer package is a sterile sealed package;

a dressing, at least two pieces of said dressing sealed within said outer casing, each piece of said dressing formed as a multi-layer structure folded to a predetermined size prior to being encased in said outer casing, each piece of said dressing having an X-ray tracing, said X-ray tracing being of a different color on each of said dressings.

Preferably, according to one embodiment of the present invention, the dressing is at least four pieces, at least two pieces of the four pieces are in a set, and the color of the X-ray tracing member on each dressing in each set of the dressings is different.

Preferably, according to one embodiment of the present invention, the outer cover is made of a soft material or a hard material, the outer cover comprises a top layer and a bottom layer, the top layer is connected with the edge of the bottom layer in a sealing manner, and at least two pieces of the dressing are sealed between the top layer and the bottom layer.

Preferably, according to an embodiment of the present invention, the top layer is a plastic film material, and the bottom layer is a paper material or a plastic film material.

Preferably, according to one embodiment of the present invention, the dressing is made of at least one layer of rayon, polyester, non-woven fabric or cotton gauze.

Preferably, according to one embodiment of the invention, the X-ray tracing member is made of a rubber material having hydrophobicity, the rubber material containing at least 60% by weight of barium sulfate.

Preferably, according to an embodiment of the present invention, the material of the X-ray tracing member is thermoplastic elastomer or polyvinyl chloride.

Preferably, according to an embodiment of the present invention, the X-ray tracing member is a strip or a square, and has a width of 3mm to 30mm, a length of 10mm to 200mm, and a thickness of 0.1mm to 2 mm.

Preferably, according to an embodiment of the present invention, the X-ray tracing element is fixed on the edge of the surface of the dressing, wherein the top surface of the X-ray tracing element is covered on the X-ray tracing element through a hot-melt adhesive sheet, and a fixing element for fixing the X-ray tracing element is covered on the top surface of the hot-melt adhesive sheet, and the fixing element is made of a non-woven fabric or a plastic film.

Preferably, according to one embodiment of the invention, the plurality of X-ray tracing members are all of different colors, and the colors of the X-ray tracing members are different from the color of the organ of the patient and the color of the blood-impregnated dressing.

Preferably, according to one embodiment of the invention, the predetermined dimensions of the dressing are configured to have a width of 5cm to 30cm and a length of 5cm to 30 cm.

The surgical sterile dressing bag provided by the invention is used for packaging a predetermined number of dressings through an outer bag, through more systematic and accurate counting, the dressings are not easy to leave behind in a patient body, the counting is easier and more accurate after surgery, and the X-ray tracking piece with higher visibility is fixed on the dressings, so that the X-ray tracking capability is improved, the visibility of the dressings before and after surgery is improved, and the dressings are easier to detect under X-rays when minor surgery is performed due to the fact that the X-ray tracking piece is wider, so that the dressings are easier to take out from the patient body, and the X-ray tracking pieces with different colors are used as visual aids, so that the counting standard of the dressings is more accurate.

Additional aspects and advantages of the invention will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the invention.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the structures shown in the drawings without creative efforts.

FIG. 1 is a schematic diagram of a surgical sterile dressing pack provided by the present invention;

FIG. 2 is an exploded view of the surgical sterile dressing package provided by the present invention;

figure 3 is another exploded view of the surgical sterile dressing package provided by the present invention.

The reference numbers illustrate:

10. outsourcing; 101. a top layer; 102. a bottom layer; 20. a dressing; 30. an X-ray tracker; 40. a fixing member; 50. and (4) thermally melting the film.

The implementation, functional features and advantages of the objects of the present invention will be further explained with reference to the accompanying drawings.

Detailed Description

Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the accompanying drawings are illustrative only for the purpose of explaining the present invention, and are not to be construed as limiting the present invention.

The present invention has been completed based on the following studies and findings of the inventors:

the gauze sheet with X-ray tracing lines is composed of a gauze sheet and rubber threads which are usually attached to the surface of the dressing by hot pressing on the gauze with a heated roller. Generally, sterile dressings with X-ray tracing are packed with 5 or 10 pieces of gauze. The conventional sizes are (7.5cm X7.5 cm) (10cm X10 cm) and (20cm X10 cm), unlike the larger size abdominal pad used for larger procedures, the gauze piece with X-ray tracing lines does not need to be provided with a retrieval handle. In addition, the X-ray tracing member for the gauze sheet with X-ray tracing lines is a piece of rubber thread, rather than a wider piece of barium for a larger size abdominal pad.

Before the surgical dressing is used for surgery, it must be packaged in a sealed package or rigid box and sterilized by common sterilization methods, such as ethylene oxide (ETO), gamma irradiation, electron beam, or steam sterilization. A surgical sterile dressing contains multiple pieces of dressing, and from 2 to 10 pieces per package depending on the application. When used as a dressing with X-ray tracing, there are typically 5 or 10 dressings in a sterile dressing pack, and depending on the complexity of the procedure and the site of the procedure, one or more sterile X-ray tracing packs may be required.

Since the X-ray tracing dressing was marketed in the united states 40 years ago, the use of X-ray tracing dressings has been spread around the world. It is estimated that annual X-ray traced sterile dressing packets are used in amounts exceeding 1000 billion packets. Although it is used in very high quantities around the world and has been used for many years, there has not been any significant improvement in the safety of X-ray tracked dressings. Although many of the following noted disadvantages and undesirable problems have been reported, most of the X-ray tracked dressings in use today are roughly the same design and function as the original version of the invention 40 years ago:

(1) because the X-ray is thinner, the X-ray tracing line can not be detected by the X-ray.

(2) After surgery, when the entire dressing is saturated with blood, the X-ray trace is usually dark green or dark blue, barely visible to the naked eye.

(3) A common problem with X-ray tracing dressings is that the X-ray tracing lines break and fall off the dressing surface.

In addition to the common safety issue complaints discussed above, another major safety issue with surgical dressings is that the dressing may be left behind in the patient after surgery. During the procedure, for example, a sterile dressing pack of 5X-ray traced dressings per pack is used as an illustration of the dressing counting protocol:

step 1, operating room staff calculate the number of dressings in each sterile dressing bag to ensure that there are indeed 5 dressings in the bag.

Step 2, if a plurality of sterile dressing packets are required for the operation, all the sterile dressing packets are opened and counted to ensure that each packet has five dressings.

Step 3, adding the total number of the surgical dressings to be equal to (the number x 5 of the used packs).

Step 4, if there is a difference in the number of any packages, the defective packages cannot be used and will be submitted to the supplier as a complaint.

And 5, collecting and calculating all used dressings with the X-ray tracing piece after the operation so as to ensure that the number of the dressings calculated before and after the operation is the same.

Step 6, if the numbers are different, the patient will undergo X-ray examination to find the dressing left in the body.

Although the standard counting scheme described above has been widely used in hospitals around the world, there are many reports that the dressing remains in the patient after surgery. In the U.S. hospital, there are several types of safety improvement systems used for X-ray tracking dressings, however, all of these safety improvement systems result in a significant increase in the cost of the X-ray tracking dressing.

Based on the extensive studies described above, the inventors found that in order to make the use of X-ray tracing dressings safer, the following three main improvements were required:

(1) the dressing visibility before and after the operation is higher: most of the dressing with the X-ray tracing member has a dark green or dark blue X-ray tracing line thereon. The X line width is about 0.5 mm and the thickness is about 0.5 mm. After surgery, a white dressing is often saturated with blood and turns deep red. X-ray trace lines of deep blue or deep green are also difficult to see because of their narrow width. In the united states, a company is selling a special piece of X-ray gauze having both white and blue colors to make the dressing look more visible even when soaked in blood. However, this particular piece of X-ray gauze is 2 times more expensive than a conventional dressing. Therefore, their use is limited to only a few hospitals in the united states.

(2) A more systematic approach to ensure accurate counting of surgical dressings: it is believed that when multiple packs of absorbent dressings are used, counting of a large number of dressings with the same physical appearance is prone to mental fatigue and point errors. In addition, the dressing counting procedure is also different before and after the operation. For example: for a procedure requiring 10 packs of X-ray traced sterile dressing packs (5 sheets/pack) prior to surgery, the count of dressings was repeated 10 times in 5 packs (or groups). In contrast, the count of dressings is not calculated in groups of five pieces (or one by one) but from 1 to 50 after surgery. Comparing the two methods, it can be easily understood that the counting method of the five-piece group is more accurate and reliable. In the united states, there are companies selling gauze pieces with X-ray tracing lines, each piece of gauze being attached with a two-dimensional bar code that can be scanned and recorded by a computer before and after an operation. However, this special X-ray traced line gauze piece costs about 3 times more than the ordinary gauze piece. Therefore, their use is limited to only a few hospitals in the united states.

(3) Dressing with X-ray tracker has better X-ray detectability: in surgery, X-ray gauze sheets are commonly used to protect certain organs from sharp objects, such as stainless steel needles. These organs may not be near the surgical site. The X-ray gauze piece may need to be twisted or squeezed to be inserted into the small space between the organs. Therefore, when the protected organ blocks the X-ray, it is difficult to find such a twisted piece of X-ray-bearing gauze if the thin X-ray is not positioned in a direction that is advantageous for detection by an X-ray machine. In fact, some american medical facilities have recognized the problem of poor detectability of thin X-ray tracing lines, which require two separate X-ray tracing lines on a sheet of X-ray-bearing gauze. However, this particular double X-ray gauze piece is 2 times more expensive than a conventional dressing. Therefore, their use is limited to only a few hospitals in the united states.

In light of the problems described above, the inventors conducted extensive studies on various materials, and invented a surgical sterile dressing pack which can avoid the dressing remaining in the patient after surgery, and which is significantly reduced in cost, and can ensure easier and more accurate counting after surgery.

The surgical sterile dressing pack according to embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

Referring to fig. 1, in an embodiment of the present invention, there is provided a surgical sterile dressing pack comprising: the outer package 10, the outer package 10 is a sterile sealed package; the dressing 20, at least two dressings 20 are sealed in the outer package 10, each dressing 20 is formed into a multi-layer structure which is folded into a predetermined size before being packaged in the outer package 10, each dressing 20 has an X-ray tracing member 30, and the X-ray tracing members 30 have different colors.

The surgical sterile dressing bag provided by the invention is used for packaging a predetermined number of dressings 20 through an outer package 10, through more systematic and accurate counting, the dressings 20 are not easy to leave in a patient body, the counting is easier and more accurate after surgery, a higher-visibility X-ray tracking piece 30 is fixed on the dressings 20, the X-ray tracking capability is improved, and the visibility of the dressings 20 before and after surgery is improved.

Further, the dressings 20 are at least four pieces, with at least two of the at least four pieces in a set, and the X-ray tracing member 30 on each dressing 20 in each set of dressings 20 is of a different color. Wherein, can be with the same colour as a set of, for example 5X-ray tracking pieces 30 of the same colour are a set of, can have the different colours of multiunit to combine together in every aseptic dressing package, then can calculate by the multiunit in the use for it is more convenient to count.

Referring again to fig. 1, the casing 10 is made of a soft material or a hard material, the casing 10 includes a top layer 101 and a bottom layer 102, the top layer 101 is hermetically connected with the bottom layer 102 at the edge, and at least two pieces of dressing 20 are hermetically sealed between the top layer 101 and the bottom layer 102.

Further, the top layer 101 is a plastic film material, and the bottom layer 102 is a paper material or a plastic film material.

In the embodiment of the present invention, the outer package 10 is an aseptic package, the top layer 101 is a plastic film, and the bottom layer 102 is a paper or plastic film, wherein the plastic film can be a transparent plastic film, and after the top layer 101 and the bottom layer 102 are sealed tightly, bacteria invasion must be prevented, so that the top layer 101 and the bottom layer 102 can be sealed tightly by heat sealing, ultrasonic sealing, film sealing or air sealing, and a part of the seal edge of the top layer 101 and the bottom layer 102 can be sealed by tearing so as to be opened quickly when in use.

Further, the dressing 20 is made of at least one layer of rayon, polyester, non-woven fabric or cotton gauze.

Wherein the X-ray tracing member 30 is made of a rubber material having hydrophobicity, and the rubber material contains at least 60% by weight of barium sulfate.

Further, the material of the X-ray tracing member 30 is thermoplastic elastomer or polyvinyl chloride.

In an embodiment of the invention, the rubber material is Polyethylene (PVC) or thermoplastic elastomer (TPE) containing about 60% by weight of barium sulphate, which is added to the rubber in order to increase the density of the material for detection by X-ray.

Referring to fig. 2 and 3, the X-ray tracing member 30 has a long bar shape or a square shape, a width of 3mm to 30mm, a length of 10mm to 200mm, and a thickness of 0.1mm to 2 mm.

Wherein, the X-ray tracing member 30 is a strip or a square, generally a sheet-like X-ray tracing sheet, the X-ray tracing member 30 replaces the line, the preferred width of the X-ray tracing member 30 is about 10mm, which is 20 times of the width of the ordinary X-ray tracing line, the length of the X-ray tracing member 30 can also range from 3 cm to 10cm, generally, the width of the X-ray tracing member 30 is much wider than the width of the X-ray tracing line, so that the X-ray can detect it more easily, and the wider X-ray tracing member 30 is not easy to break.

Further, the X-ray tracing member 30 is fixed on the edge of the surface of the dressing 20, wherein the top surface of the X-ray tracing member 30 is covered on the X-ray tracing member 30 by the hot-melt adhesive sheet 50, and the fixing member 40 is covered on the top surface of the hot-melt adhesive sheet 50 for fixing the X-ray tracing member 30, and the material of the fixing member 40 is non-woven fabric or plastic film.

In order to attach the X-ray tracing member 30 to the surface of the dressing 20 in a relatively efficient manner, the thermal melting film 50 is melted to adhere the X-ray tracing member 30 to the surface of the dressing 20 and is fixed by the fixing member 40, wherein the fixing member 40 is a non-woven fabric or a plastic film, and a non-woven fabric or a plastic film is further covered on the thermal melting film 50, so that the X-ray tracing member 30 can be firmly adhered to the surface of the dressing 20 and a fabric is covered, thereby avoiding the safety problem that the X-ray tracing member 30 falls off from the surface of the dressing 20, and for the attachment of the X-ray tracing member 30 to the surface of the dressing 20, a thin non-woven fabric with a thickness of about 0.2 mm can be used to cover the X-ray tracing member 30 and the thermal melting film 50, and the color of the X-ray tracing member 30 is not covered.

Further, the plurality of X-ray trackers 30 are all of different colors, and the X-ray trackers 30 are of different colors than the patient's organ and the blood-saturated dressing 20.

In the embodiment of the present invention in which the X-ray tracing member 30 is made of thermoplastic elastomer TPE or polyethylene PVC, which are hydrophobic materials, the color of the X-ray tracing member 30 will be prominent even if the dressing 20 is saturated with blood after surgery.

Preferably, according to an embodiment of the present invention, the predetermined dimension is configured to have a width of 5cm to 30cm and a length of 5cm to 30 cm. It will be appreciated that more space can be saved by folding the dressing 20 to a predetermined size to place more dressings 20.

The above-described embodiment of the present invention is illustrated wherein the color of the X-ray tracing member 30 on each dressing 20 in a sterilization bag is different from the color of the X-ray tracing members 30 on the other dressings 20, such as every 5X-ray tracing members 30 on every 5 dressings 20 are different from the color of the X-ray tracing members 30 on the other dressings 20 when 2 to 5 dressings 20 are contained in a sterilization bag; if 10 dressings 20 are required to be packaged in a sterile dressing, there are 2 groups of dressings 20 with X-ray trackers 30 of different colors for each 5 sheets.

Additionally, for procedures requiring multiple sterile packs of dressings 20, it is generally necessary to collect and count 50 dressings 20, but counting many items with the same appearance can cause mental fatigue to medical personnel and can easily lead to erroneous counts, while counting can be assisted with a 5-piece set of different colors, and more systematic accuracy can be achieved by using multiple sets of X-ray trackers 30 of different colors on dressings 20 in the same sterile pack.

Alternatively, a procedure requiring the use of 10 packs of 5 pieces of dressing 20 with X-ray tracing 30 is illustrated:

(1) the conventional counting method comprises the following steps: calculating 10 conventional knee joint dressing packs post-operatively means collecting all 50 identical dressings 20 and then counting from 1 to 50, which easily results in an erroneous count.

(2) The counting method comprises the following steps: for example, counting the number of dressings 20 with 10-strap X-ray trackers 30, the collected dressings 20 are first divided into 5 groups of 5X-ray trackers 30 of different colors for each group of dressings 20, and the number of collected 5 per group is counted.

When comparing the two counting methods, the invention provides a significantly more systematic and accurate counting of the dressings 20 after surgery by the sterile dressing packs, and therefore the different coloured X-ray tracers 30 of each sterile dressing pack provide a very effective visual aid, not only to aid the counting process, but also to improve the accuracy of the counting.

The following table compares the dressing 20 with the X-ray tracing 30 of our inventive sterile dressing pack with the three other safety-improved dressings 20 described above. All test dressings 20 were 10cm x 10cm in size and 8 layers. The X-ray tracing piece 30 of the dressing packet of the invention has the width of 10mm and the length of 100 mm; while the other dressings 20 had an X-ray trace width of 0.5 mm and a length of 100 mm.

As shown in the above table, the overall effectiveness of the sterile dressing package of the present invention in terms of safety improvement is much superior to several other safety-improved dressings 20.

In addition, to verify the various parameters of the present invention, further samples were tested, which varied and varied in materials and configuration as follows:

(1) different surgical dressing 20 materials: cotton gauze, rayon non-woven fabric, polyester non-woven fabric or cotton non-woven fabric.

(2) Different sizes of X-ray tracking dressing 20: 7.5cm x 7.5cm, 10cm x 10cm, 20cm x 10cm and 20cm x 20 cm).

(3) The number of dressings 20 in the sterile dressing bag varies: 2 blocks, 6 blocks and 12 blocks.

(4) The X-ray tracker 30 width is different: 3mm and 30 mm.

(5) The X-ray tracker 30 has different lengths: 10cm and 20 cm.

For all of the above-described variations of the sterile dressing packs of the invention, it was found that their visibility and traceability to X-rays were similar to the results in column 1 of the above table.

In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above are not necessarily intended to refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, various embodiments or examples and features of different embodiments or examples described in this specification can be combined and combined by one skilled in the art without contradiction.

The above-mentioned embodiments are only used for illustrating the technical solutions of the present invention, and not for limiting the same; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; such modifications and substitutions do not substantially depart from the spirit and scope of the embodiments of the present invention, and are intended to be included within the scope of the present invention.

Claims

1. A surgical sterile dressing pack, comprising:

the outer package is a sterile sealed package;

a dressing, at least four pieces of the dressing being sealed within the outer casing, each piece of the dressing being formed as a multi-layer structure folded to a predetermined size prior to being encased in the outer casing; each dressing is provided with an X-ray tracing piece, at least two pieces of the four pieces form a group, and the color of the X-ray tracing piece on each dressing in each group of the dressings is different so as to assist in counting the dressings;

the predetermined dimensions of the dressing are configured to be 5cm to 30cm in width and 5cm to 30cm in length.

2. The surgical sterile dressing pack according to claim 1, wherein the outer cover is a soft or hard material, the outer cover comprises a top layer and a bottom layer, the top layer is hermetically connected with the edge of the bottom layer, and at least two pieces of the dressing are hermetically sealed between the top layer and the bottom layer.

3. The surgical sterile dressing pack according to claim 2, wherein said top layer is a plastic film material and said bottom layer is a paper material or a plastic film material.

4. The sterile surgical dressing package according to claim 1, wherein said dressing is made of at least one layer of rayon, polyester, non-woven fabric or cotton gauze.

5. A surgical sterile dressing pack according to claim 1, wherein said X-ray tracing member is made of a hydrophobic rubber material containing at least 60% by weight of barium sulphate.

6. A surgical sterile dressing pack according to claim 4 wherein the material of the X-ray tracing member is a thermoplastic elastomer or polyvinyl chloride.

7. A surgical sterile dressing package according to claim 1, wherein said X-ray tracing member is elongate or square and has a width of 3mm to 30mm, a length of 10mm to 200mm and a thickness of 0.1mm to 2 mm.

8. The surgical sterile dressing pack according to claim 1, wherein the X-ray tracing member is fixed on the edge of the dressing surface, wherein the top surface of the X-ray tracing member is covered on the X-ray tracing member through a hot-melt adhesive sheet, and a fixing member for fixing the X-ray tracing member is covered on the top surface of the hot-melt adhesive sheet, and the fixing member is made of non-woven fabric or plastic film.

9. The surgical sterile dressing package according to claim 1, wherein a plurality of said X-ray tracers are all of a different color, and said X-ray tracers are of a different color than the patient's organ and the blood-saturated dressing.